PSMA PET to predict treatment response in advanced prostate cancer

PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN), an Italian Multicenter Study

This will test whether PSMA PET scans can help predict how advanced prostate cancer will respond to systemic treatments such as hormone therapy, chemotherapy, or PSMA-targeted radioligand therapy.

Quick facts

• Study type: Observational
• Enrollment: 1300 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (other)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Bologna, Italy and 3 other locations)
• Trial ID: NCT07089550 on ClinicalTrials.gov

What this trial studies

This prospective, observational multicenter registry will enroll patients with advanced prostate cancer (hormone-sensitive or castration-resistant) undergoing PSMA PET/CT before systemic treatment. Quantitative PSMA PET parameters — including lesion count, metabolic tumor volume (MTV), SUVmax, and SUVmean — will be measured and recorded across participating centers. Investigators will correlate these imaging biomarkers with clinical outcomes such as progression-free and overall survival and with response to a range of systemic therapies (abiraterone, enzalutamide, apalutamide, darolutamide, taxanes, PARP inhibitors, radiotherapy, and PSMA-directed radioligand therapy). Data collection is planned over approximately nine years to allow prospective longitudinal assessment and development of prognostic models.

Who should consider this trial

Good fit: Men with histologically confirmed advanced, PSMA-positive prostate cancer (either hormone-sensitive or castration-resistant) who are scheduled to start or change systemic therapy, can undergo PET/CT, and can provide informed consent.

Not a fit: Patients with significant neuroendocrine differentiation, those unable to remain still for PET/CT, or those with an active non-skin second malignancy are unlikely to benefit from the imaging-based predictive aims.

Why it matters

Potential benefit: If successful, PSMA PET-derived measures could help doctors identify patients at higher risk of poor outcomes and tailor treatment choices or monitoring intensity.

How similar studies have performed: Retrospective and exploratory reports have suggested PSMA PET metrics correlate with outcomes, but prospective multicenter evidence across diverse systemic therapies remains limited.

Eligibility criteria

Inclusion Criteria:

* Histological diagnosis of advanced prostate cancer (excluding neuroendocrine carcinoma);
* Patients undergoing PSMA PET for pre-treatment disease staging;
* Candidates to receive one or more of the following systemic therapies, in combination or alone: abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel, olaparib, radiotherapy, lutetium-177-PSMA, actinium-225-PSMA;
* Provision of signed informed consent for study participation and data handling.

Exclusion Criteria:

* Inability to remain supine and still for the PET/CT image acquisition;
* Prostate cancer with a known significant neuroendocrine component;
* Presence of another concurrent malignancy, with the exception of non-melanoma skin cancer.

Where this trial is running

Bologna, Italy and 3 other locations

• Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy, Italy (RECRUITING)
• Azienda Ospedaliera Santa Croce e Carle - ospedale Santa Croce — Cuneo, Italy, Italy (RECRUITING)
• U.O. Medicina Nucleare, IRCCS Ospedale Policlinico San Martino — Genova, Italy, Italy (RECRUITING)
• UOC Medicina Nucleare, AOU Policlinico G.Martino — Messina, Italy, Italy (RECRUITING)

Study contacts

• Principal investigator: Andrea Farolfi — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Andrea Farolfi, MD

Conditions: PSMA Positive Tumors or Tumor Tissues, Prostate Cancer Metastatic, PSMA PET/CT, mCRPC, mHSPC